Efficacy of dexmedetomidine versus midazolam sedation on extubation time in mechanically ventilated preterm infants: a randomized controlled multicenter trial (DEXPRE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trial duration

17 Oct 2025 → ongoing

Decision date (initial)

2024-08-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

French Ministry of Health

External identifiers

EU CT number

2023-508785-16-00

ClinicalTrials.gov

NCT06878703

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the efficacy of dexmedetomidine-based sedation versus midazolam-based sedation in very preterm neonates.

Secondary objectives 6

1. Use of adjuvant anesthetic agents, including opioids between the start of experimental treatment and extubation, 2.Quality of sedation,
2. Quality of sedation
3. Extubation failure 24 hours after extubation
4. Withdrawal syndrome (Finnegan score >8)
5. Hemodynamic and respiratory adverse effects between start of the sedation and 84 hours after treatment discontinuation,
6. In hospital morbi mortality.

Conditions and MedDRA coding

Very preterm neonate (gestational age at birth < 32 WG) with corrected gestational age <45 WG) with indication for sedation in the context of invasive mechanical ventilation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Patient admitted in NICU
2. Randomization criteria 5 : no concomitant use of curare agent
3. randomization criteria 6 : no previous extubation within 7 days
4. Randomization criteria 7 : no Clonidine treatment
5. randomisation criteria 7 : no hemodynamic instability
6. randomisation criteria 8 : no palliative care
7. Gestational age at birth < 32 weeks of gestation (WG),
8. Corrected gestational age <45 weeks of gestation (WG)
9. Randomization criteria 1 : indication for sedation in the context of invasive mechanical ventilation
10. Randomization criteria 2 : elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent),
11. Randomization criteria 3 : presence or plan of a venous access,
12. Randomization criteria 4 : no medical contraindication related to the administration of dexmedetomidine or midazolam,
13. Holder(s) of parental authority must sign the written or electronic informed consent
14. Holder(s) of parental authority must sign the written or electronic informed consent

Exclusion criteria 5

1. Polymalformative syndrome
2. Palliative care,
3. Inclusion in another clinical trial on medicinal products, clinical investigation protocol concerning a medical device or interventional protocol not concerning a health product.
4. Clonidine treatment
5. Parents who don't understand French

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.

Secondary endpoints 7

1. Administration of opioid agents during the period of interest, i.e., from the start of treatment (DEX or midazolam) until extubation
2. Time (in hours) between start of sedation and achievement of a normal Comfort B score (ie. between 11 and 17).
3. Intubation rate at 24 hours after extubation.
4. Proportion of patients with at least one value of the Finnegan score > 8 from within 3 days after extubation.
5. Hemodynamic and respiratory adverse event from start of the sedation until 84 h after the sedative is stopped defined as: bradycardia, hemodynamic instability, desaturation <85% despite optimization of mechanical ventilation, reintubation
6. In-hospital mortality
7. Severe neonatal morbidity

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Clément CHOLLAT

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Clément CHOLLAT

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications